4D Molecular Therapeutics Inc. Emeryville , CA 94608
Posted 2 months ago
GENERAL SUMMARY:
The Principal Data Scientist: Statistical Programmer will report to the VP, Data Science and will focus on applying programming methodology for implementing statistical analyses using SAS for in-house deliverables and performing quality review of outsourced statistical deliverables. They will participate as active members of a cross-functional team to plan, lead and execute the tasks required to support the clinical development for the assigned programs.
RESPONSIBILITIES:
Provide statistical programming support to assigned projects, including, as needed, generating programming codes for inhouse data analysis
Work closely with biostatisticians to review the SAP and be responsible for developing data/analysis program specifications based on the SAP.
Maintain complete and auditable programming documentation for analysis of clinical trials.
Contribute to the development, documentation, and maintenance of reusable programming code library
Collaborate with IT to set up/maintain the statistical computing infrastructure (e.g., SAS server)
May act as a biostatistician on small-scale projects
Collaborate with various functions to ensure robust CRF/EDC development and quality data collection for the assigned clinical trials
Oversee the biometrics vendors to ensure the prompt and quality statistical deliverables
Provide quality review of outsourced statistical deliverables (including inhouse double programming to QC as needed) and coordinate the inhouse review comments
Contribute to the development of functional-level standards, SOPs, work instructions, and templates
Represent both biostatistics and statistical programming on study/project teams
Stay abreast of industry development in biostatistics/statistical programming fields and apply to appropriate systems and processes
Other duties as assigned: nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time
QUALIFICATIONS:
Education:
Experience:
Work experience in biotech/pharmaceutical industry or medical research for a minimum of 8 years (or 4 years for a PhD with relevant training)
Experience in clinical development
Experience in ophthalmology and/or biologic/gene therapy a plus
Skills:
Strong SAS programming skills required with proficiency in SAS/BASE, SAS Macros, SAS/Stat and ODS (proficiency in SAS/SQL, SAS/GRAPH or SAS/ACCESS is a plus)
Good understanding of standards specific to clinical trials such as CDISC, SDTM, and ADaM, MedDRA, WHODRUG
Experience with all clinical phases (I, II, III, and IV) is strongly desirable
Experience with BLA/IND submissions is strongly desirable
Good understanding of regulatory requirements for submission-related activities (e.g., CDISC, CDASH, eCTD) and CRT packages (e.g., XPTs Define/xml, reviewer's guide, analysis metadata report, executable programs) is desirable
Able to run the P21 checks is a plus
Proficiency in R programming is a plus
Knowledge of applicable GCP/FDACHMP//ICH/HIPPA regulations
Proficiency in Microsoft Office Apps, such as WORD, EXCEL, and PowerPoint (familiar with the "Chart" features in EXCEL/PowerPoint a plus)
Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a fast-paced environment with shifting priorities and/or conflicting deadlines
Excellent written and verbal communication skills and strong team player with a demonstrated track record of success in a cross-functional team environment
Proven conceptual, analytical, and strategic thinking
Good interpersonal and project management skills
Proactively identifies risks, issues, and possible solutions
Base salary compensation range:
Outside of Bay Area Range: $176,000/yr - $198,000/yr
Bay Area Range: $178,000/yr - $211,000/yr
Please note that the base salary compensation range and actual salary offered to the final candidate depends on various factors: the candidate's geographical location, relevant work experience, skills, and years of experience.
4D Molecular Therapeutics Inc.